i i Heinz Kurz GmbH Medizintechnik Tuebinger Str. 3 72144 Dusslingen Germany Phone +49 (0)7072 9179-0 Fax +49 (0) 7072 91 79 79 Email: [email protected] Internet: www.kurzmed.com
Kurz Medical, Inc.
5126 South Royal Atlanta Drive Tucker, GA 30084
USA
Phone 770.349.6330 Fax 770.934.3384
MR Information Date: March 11, 2014
Dear Medical Professional:
Heinz Kurz GmbH Medizintechnik manufactures implants for surgeons specializing in otorhinolaryngology. These are designed for permanent Implantation in the patient.
Examinations with magnetic resonance imaging (MRI) techniques are employed increasingly for all types of diagnostic purposes. Potential hazards that MR imaging may have as a result of the implant included magnetic field interactions, heating, induced electrical currents, and possible artefacts.
The MR Labeling information is based on rationale and worst case analysis for every product group.
For further information please contact,
Heinz Kurz GmbH Medizintechnik
G E N E R A L INFORMATION
Currently all available
• Passive Middle Ear Implants for Tympanoplasty and Stapedioplasty • Implants for Rhinology, Ophthalmology and Laryngology
manufactured by Heinz Kurz GmbH are
/ \R Conditional.
MR Conditional means that non-clinical testing has demonstrated that the implant can be scanned safely under specific conditions. Scanning under different conditions may result in severe patient injury. Details on the MR conditions for each Implant are given on the following pages.
A safe MR scan is not possible for all Ventilation tubes. There are some Ventilation Tubes which are
MR Conditional.
Please make sure in case of MR scanning with Ventilation Tubes that the complete information about the implant is available. If the Reference Number (REF Number) of the Ventilation Tube is unknown or unclear, do not perform a MR scan.
For details on MRI settings for each product please see the following pages.
Information for all products, listed by Reference Number and Product Name, is available on the following pages.
The MR information on the following pages is based on rationale and worst case analysis for every product group. The MR information cannot be transferred to other products that are not listed in this document. If the REF number of the products is unknown or unclear do not perform a MR scan.
Section 1.1 MRI Safety information Tympanoplasty
Non-clinical testing has demonstrated the products listed below are MR Conditional. They can be scanned safely under the following conditions listed beneath the table.
REF Number Brand Name Material
1002020/1002010 TTP VARIAC / VARIO System Partial Pure Titanium 1002023-1002033 Duesseldorf Type Bell Pure Titanium 1002073-1002080 München"-""" Bell Partial Prothesis Pure Titanium 1002223-1002230 TTP Tuebingen Type Bell Pure Titanium 1002250- 1002257 CliP Partial Prosthesis Pure Titanium 1002350- 1002357 CliP Partial FlexiBAL Pure Titanium 1002423-1002430 Malleus Notch Prosthesis (MNP) Partial Pure Titanium
1002473-1002480 Bell Partial Vincent Pure Titanium
1002610/1002612 Angular Prosthesis Pure Titanium
1002615/1002617 Angular CliP Prosthesis Pure Titanium 1002620 Incus Bridge Prosthesis (IBP) Pure Titanium 1004020/1004010 TTP VARIAC / VARIO System Total Pure Titanium 1004034-1004049 Duesseldorf Type Aerial Pure Titanium 1004074-1004089 München'"'"^ Aerial Total Prothesis Pure Titanium 1004234-1004249 TTP Tuebingen Type Aerial Pure Titanium 1004434-1004449 Malleus Notch Prosthesis (MNP) Total Pure Titanium 1004458-1004462 Regensburg Type Prosthesis Pure Titanium
1004478-1004494 Aerial Total Vincent Pure Titanium
1004930/1004975 ü Connector/ Spider Pure Titanium
• Static magnetic field of 1.5 T, 3.0 T, or 7.0 T.
• Maximum spatial gradient field of 3000 Gauss/cm (30 T/m)
• Maximum MR System reported, whole body averaged specific absorption rate (SAR) of < 2 W/kg (Normal Operating Mode)
• Follow the additional MRI Safety Instructions as specified in Section 1.2.
Under the scan conditions defined above, the Tympanoplasty Prostheses listed in the table above are expected to produce a maximum temperature rise of 2.8°C after 15 minutes of continuous scanning.
In non-clinical testing, the Image artifact caused by the device extends approximately 6 mm from the Tympanoplasty Prosthesis when imaged with a gradient echo pulse sequence and a 7.0 tesla MRI System.
Section 2.1 MRI Safety Information Stapedioplasty
I
Non-clinical testing has demonstrated the products listed below are MR Conditional. They can be scanned safely under the following conditions listed beneath the table.
REF Number Brand Name Material
1006103 - 1006120; 1006153 -1006170 K-Piston Stapes Prosthesis Pure Titanium 1006203 - 1006211; 1006253 -1006261 Soft CliP Prosthesis Pure Titanium 1006523-1006529 Lenticle Cup Prosthesis Pure Titanium 1006600 - 1006602; 1006650 - 1006652 Angular Piston Prosthesis Pure Titanium 1006708 - 1006713; 1006758 - 1006763 CliP Piston MVP Pure Titanium 1006803 -1006811; 1006853 - 1006861 CliP Piston äWengen Pure Titanium
1006960 Malleus Replacement Prosthesis Pure Titanium
• static magnetic field of 1.5 T, 3.0 T, or 7.0 T.
• Maximum spatial gradient field of 3000 Gauss/cm (30 T/m)
• Maximum MR System reported, whole body averaged specific absorption rate (SAR) of < 2 W/kg (Normal Operating Mode)
• Follow the additional MRI Safety Instructions as specified in Section 2.2
Under the scan conditions defined above, the Stapedioplasty Prostheses listed in the table above are expected to produce a maximum temperature rise of 2.9°C after 15 minutes of continuous scanning.
In non-clinical testing, the Image artifact caused by the device extends approximately 5 mm from the Stapedioplasty Prosthesis when imaged with a gradient echo pulse sequence and a 7.0 tesla MRI System.
Section 2.2. - Additional MRI Safety Instructions • Body coil only was used for testing as a worst-case assumption.
Section 3.1 IVIRI Safety Information Ventilation Tubes 1
MR UNSAFE
Following products are MR UNSAFE:
REF Number Brand Name Material
1015002/ 1015004
Tuebingen Type Ventilation Tubes with wire Gold-Platinum / Stainless Steel 1015011/
1015013
Tuebingen Type Ventilation Tubes with wire Gilded Silver / Stainless Steel 1015031/
1015033
Tuebingen Type Ventilation Tubes with wire Pure Titanium / Stainless Steel 1015072 Minimal Type Ventilation Tube Gold coated Stainless Steel
Section 4.1 MRI Safety Information Ventilation Tubes 2
Non-clinical testing has demonstrated the products listed below are MR Conditional. They can be scanned safely under the following conditions listed beneath the table.
REF Number Brand Name Material
1015001/1015003 Tuebingen Type Ventilation Tubes Gold-Platinum 1015010/1015012 Tuebingen Type Ventilation Tubes Gilded Silver 1015020/1015022 Tuebingen Type Ventilation Tubes Titanium coated 1015030/1015032/1015036 Tuebingen Type Ventilation Tubes Pure Titanium 1015051/1015053/1015055 Beveled Type Ventilation Tubes Gold-Platinum 1015064/1015065 Ventilation Tubes Long Term Gold-Platinum 1015074 Trocar Ventilation Tubes (TVT) Gilded Silver 1015075 Trocar Ventilation Tubes (TVT) Pure Titanium
• static magnetic field of 1.5 T, 3.0 T, or 7.0 T.
• Maximum spatial gradient field of 3000 Gauss/cm (30 T/m)
• Maximum MR System reported, whole body averaged specific absorption rate (SAR) of < 2 W/kg (Normal Operating Mode)
• Follow the additional MRI Safety Instructions as specified in Section 4.2
Under the scan conditions defined above, the Ventilation Tubes listed in the table above are expected to produce a maximum temperature rise of 2.6°C after 15 minutes of continuous scanning.
In non-clinical testing, the Image artifact caused by the device extends approximately 8 mm from the Ventilation Tube when imaged with a gradient echo pulse sequence and a 7.0 tesla MRI System.
Section 4.2 - Additional MRI Safety Instructions
• Body coil only was used for testing as a worst-case assumption.
Section 5.1 MRI Safety Information Rhinology
Non-clinical testing has demonstrated the products listed below are MR Conditional. They can be scanned safely under the following conditions listed beneath the table.
REF Number Brand Name Material
6002011 -6002016 Breathe Implant äWengen Pure Titanium
6002022 Dilatator Brusis Pure Titanium
• static magnetic field of 1.5 T, 3.0 T, or 7.0 T.
• Maximum spatial gradient field of 3000 Gauss/cm (30 T/m)
• Maximum MR System reported, whole body averaged specific absorption rate (SAR) of < 2 W/kg (Normal Operating Mode)
• Follow the additional MRI Safety Instructions as specified in Section 5.2
Under the scan conditions defined above, the Implants listed in the table above are expected to produce a maximum temperature rise of 3.4°C after 15 minutes of continuous scanning.
MR Image quality is compromised if the area of interest is in the same are or relatively dose to the position of the device. Therefore it may be necessary to optimize MR imaging parameters for the presence of this implant.
Section 5.2 - Additional MRI Safety Instructions
Section 6.1 MRI Safety Information Laryngology
Non-clinical testing has demonstrated the products listed below are MR Conditional. They can be scanned safely under the following conditions listed beneath the table.
REF Number Brand Name Material
5001000-5001003 TVFMI Pure Titanium
5002010-5002014 Trachea Support Ring Pure Titanium
• static magnetic field of 1.5 T, 3.0 T, or 7.0 T.
• Maximum spatial gradient field of 3500 Gauss/cm (35 T/m)
• Maximum MR System reported, whole body averaged specific absorption rate (SAR) of < 2 W/kg (Normal Operating Mode)
• Follow the additional MRI Safety Instructions as specified in Section 6.2
Under the scan conditions defined above, the implants listed in the table above are expected to produce a maximum temperature rise of 4.2°C after 15 minutes of continuous scanning.
MR Image quality is compromised if the area of interest is in the same are or relatively dose to the position of the device. Therefore it may be necessary to optimize MR imaging parameters for the presence of this implant.
Section 6.2 - Additional MRI Safety Instructions
• Body coil only was used for testing as a worst-case assumption.
7.1 MRI Safety Information Ophthalmology
Non-clinical testing has demonstrated that the products listed below are MR Conditional. They can be scanned safely under the following conditions listed beneath the table.
REF Number Brand Name Material
4001002-4001010 Upper Eyelid Implant Gold
4007002-4007010 Upper Eyelid Implant Platin-Iridium
• static magnetic field of 1.5 T, 3.0 T, or 7.0 T.
• Maximum spatial gradient field of 10000 Gauss/cm (100 T/m)
• Maximum MR System reported, whole body averaged specific absorption rate (SAR) of < 2 W/kg (Normal Operating Mode)
• Follow the additional MRI Safety Instructions as specified in Section 7.2
Under the scan conditions defined above, the implants listed in the table above are expected to produce a maximum temperature rise of 3.3°C after 15 minutes of continuous scanning.
MR Image quality is compromised if the area of interest is in the same are or relatively dose to the position of the device. Therefore it may be necessary to optimize MR imaging parameters for the presence of this implant.
Section 7.2 - Additional MRI Safety Instructions